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SYNALAR

NDA

FLUOCINOLONE ACETONIDE | N012787 | EUROFARMA INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant NCT07423442	—	Not Yet Recruiting	Nantes University Hospital	100	2026-06 → 2027-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Derma-Smoothe-FS (2023)

Total Spending

$12K

Total Claims

213

Beneficiaries

132

Avg Cost/Unit

$0.33

Spending Trend

$16K(2019)→$14K(2020)→$13K(2021)→$12K(2022)→$12K(2023)

YoY Change:-4.0%

5yr CAGR:-0.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs7 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVFLUOCINOLONE ACETONIDE (PROCESS I)

DMF 44861982

FARMABIOS SPAFLUOCINOLONE ACETONIDE

DMF 173952004

TEVA PHARMACEUTICAL INDUSTRIES LTDFLUOCINOLONE ACETONIDE - PROCESS II

DMF 238752010

HENAN LIHUA PHARMACEUTICAL CO LTDFLUOCINOLONE ACETONIDE

DMF 404062024

DR REDDYS LABORATORIES LTDInactiveFLUOCINOLONE ACETONIDE

DMF 4181961

DR REDDYS LABORATORIES LTDInactiveFLUOCINOLONE ACETONIDE ACETATE

DMF 8061964

ANTIBIOTICOS SPAInactiveFLUOCINOLONE ACETONIDE

DMF 27871976

NOBEL CHEMICALS AB DIV FINE CHEMICALS INCInactiveFLUOCINOLONE ACETONIDE

DMF 29441977

QUATRUMInactiveFLUOCINOLONE ACETONIDE

DMF 73861988

FARMABOISInactiveFLUOCINOLONE ACETONIDE

DMF 74581988

SICOR SPAInactiveFLUOCINOLONE ACETONIDE 1,2-DIHYDRO

DMF 155722001

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (3)

Sort:

#002 — 0.025%

RLDAT

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#004 — 0.01%

RLDAT

0 patents0 exclusivities▾

CREAM;TOPICAL | Approved: Approved Prior to Jan 1, 1982

#005 — 0.025%

RLDAT

0 patents0 exclusivities▾

CREAM;TOPICAL | Approved: Approved Prior to Jan 1, 1982